From Discovery to FDA Approval
Relentless discovery and development efforts culminate in US approval of ZAYNICH™
A watershed moment for India’s pharmaceutical innovation and a welcome addition to America’s antimicrobial resistance efforts
The US FDA approval of ZAYNICH™ marks a defining milestone not only for Wockhardt but also for India’s pharmaceutical industry. ZAYNICH™ is the first U.S.-approved antibacterial combination to incorporate zidebactam, a novel Gram-negative β-lactam enhancer, which is not approved for standalone therapy.
Novel mechanism of action
Zidebactam selectively targets PBP2, while cefepime provides a complementary PBP3 targeting mechanism. Clinicians can now turn to this novel β-lactam enhancer combination to address susceptible Gram-negative pathogens, specifically for the treatment of complicated urinary tract infections, including pyelonephritis, in adult patients.
Please see full indication for ZAYNICH™ below.
A symbol of commitment
The introduction of ZAYNICH™ is a testament to Wockhardt’s unwavering commitment to scientific innovation and to India’s growing capability to discover, develop, and commercialize globally relevant medicines that address critical unmet medical needs. After 30 years dedicated to antibiotic discovery, we are proud to bring this valuable medicine to our healthcare partners in America and around the world.
More than a product approval, ZAYNICH™ symbolizes the transformation of India from a predominantly generic pharmaceutical supplier into a source of innovation capable of delivering solutions to some of the world’s most pressing healthcare challenges. Wockhardt has developed 6 antibiotic programs, each granted QIDP designation from the FDA. Three address Gram-positive and three address Gram-negative pathogens.*
The achievement reflects the depth of scientific talent nurtured in India and demonstrates that Indian pharmaceutical companies can successfully navigate the long, high-risk, and scientifically demanding journey of drug discovery and development while meeting the stringent standards of the world’s most respected regulatory agencies, including the FDA.
A promising addition to the fight against antimicrobial resistance
The promising clinical trial results show the potential to address Gram-negative bacteria, including K. pneumoniae and P. aeruginosa. Multi-drug-resistant strains of these pathogens have been recognized as an urgent public health challenge, and a formidable threat in the ICU setting.
The global burden of AMR is projected to rise at an alarming pace. Against this backdrop, the emergence of ZAYNICH™ helps provide renewed hope to physicians and healthcare systems struggling with diminishing treatment options for severe resistant infections.
“This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance.”
*ZAYNICH™ is the only FDA-approved product.
References: 1. ZAYNICH (cefepime and zidebactam) US Prescribing Information. Wockhardt Bio AG; 2026. 2. Moya B, Barcelo IM, Bhagwat S, et al. WCK 5107 (zidebactam) and WCK 5153 are novel inhibitors of PBP2 showing potent "β-lactam enhancer" activity against Pseudomonas aeruginosa, including multidrug-resistant metallo-β-lactamase-producing high-risk clones. Antimicrob Agents Chemother. 2017;61(6):e02529-16. doi:10.1128/AAC.02529-16 3. Papp-Wallace KM, Nguyen NQ, Jacobs MR, et al. Strategic approaches to overcome resistance against gram-negative pathogens using β-lactamase inhibitors and β-lactam enhancers: activity of three novel diazabicyclooctanes WCK 5153, zidebactam (WCK 5107), and WCK 4234. J Med Chem. 2018;61(9):4067-4086. doi:10.1021/acs.jmedchem.8b00091 4. Rajavel M, Kumar V, Nguyen H, et al. Structural characterization of diazabicyclooctane β-lactam "enhancers" in complex with penicillin-binding proteins PBP2 and PBP3 of Pseudomonas aeruginosa. mBio. 2021;12(1):e03058-20. doi:10.1128/mBio.03058-20 5. Bhavsar S, Joshi S, Pawar S, et al. Structure activity relationship (SAR) driven design and discovery of WCK 5107 (zidebactam): novel β-lactam enhancer, potent against multidrug-resistant gram-negative pathogens. Med Chem Res. 2023;32(10):2245-2255. 6. Mushtaq S, Garello P, Vickers A, Woodford N, Livermore DM. Activity of cefepime/zidebactam (WCK 5222) against 'problem' antibiotic-resistant Gram-negative bacteria sent to a national reference laboratory. J Antimicrob Chemother. 2021;76(6):1511-1522. doi:10.1093/jac/dkab067 7. WHO updates list of drug-resistant bacteria most threatening to human health. World Health Organization. May 17, 2024. Accessed October 7, 2026. https://www.who.int/news/item/17-05-2024-who-updates-list-of-drug-resistant-bacteria-most-threatening-to-human-health 8. Kerimoglu E, Catak T, Kilinc A. Evaluation of infections caused by carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae in an intensive care unit: a retrospective study. Antibiotics (Basel). 2025;14;700. doi:10.3390/antibiotics14070700 9. Sullivan C, Fisher CR, Taenzer J. Novel antimicrobial drug development and access: U.S. government support and opportunities. U.S. Department of Health and Human Services; 2024;1-15.